Download PRODUCT INFORMATION DIFFLAM FORTE ANTI

PRODUCT INFORMATION
DIFFLAM FORTE ANTI-INFLAMMATORY THROAT SPRAY
Composition
Each mL of Difflam Forte Anti-Inflammatory Throat Spray contains 3.0mg of
benzydamine hydrochloride in mL. Each spray delivers approximately 0.5mg of
benzydamine hydrochloride. It also contains ethanol, saccharin sodium, methyl
hydroxybenzoate, glycerol, PEG-40 hydrogenated castor oil, purified water and mint
flavouring. It does not contain gluten, lactose, sugar or colour.
Pharmacology
Benzydamine is an anti-inflammatory analgesic agent structurally unrelated to the
steroid group. Benzydamine differs chemically from other non-steroidal antiinflammatory agents in that it is a base rather than an acid.
Animal models show that, when administered systemically, benzydamine is effective
against pain and oedema due to inflammatory conditions. It also inhibits granuloma
formation. At concentrations used for topical treatment, benzydamine possesses local
anaesthetic action. Benzydamine does not cause erosion of the gastric mucosa when
given orally to rats at doses of up to 100mg/kg.
The analgesic activity of benzydamine was more pronounced in models involving an
experimental inflammation rather than in non-inflammatory pain. In common with the
aspirin-like drugs, benzydamine possesses an antipyretic activity. Peripheral reflexes
were transiently inhibited after intravenous administration to cats.
Pharmacodynamics
The mechanism of anti-inflammatory action of benzydamine is not related to
stimulation of the pituitary-adrenal axis. Like other non-steroidal anti-inflammatory
agents, benzydamine inhibits the biosynthesis of prostaglandins under certain
conditions, but its properties in this respect have not been fully elucidated. The
stabilising effect on cellular membranes may also be involved in the mechanism of
action.
Pharmacokinetics
Benzydamine is well absorbed following oral administration. Following topical
administration, benzydamine is well absorbed into the inflamed local mucosa where it
exerts anti-inflammatory and local anaesthetic actions. Plasma benzydamine levels
following use are low and proportionate to the amount actually ingested.
Benzydamine and its metabolites are excreted largely in the urine. Metabolism is
largely by oxidative pathways, although dealkylation can be shown.
Difflam Forte Throat Spray-vs1.doc
Benzydamine has been detected in blood and urine following gargling of solution
form. Most of the absorbed dose is eliminated in the first 24 hours. Repeated
administration for 7 days does not result in accumulation of benzydamine in plasma.
Indications
Difflam Forte Anti-Inflammatory Throat Spray is indicated for the temporary relief of
painful conditions of the mouth and throat including tonsillitis, sore throat, radiation
mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions,
post orosurgical and periodontal procedures.
Contraindications
Patients with known hypersensitivity to benzydamine or to the other components
listed.
Precautions
If a sore throat is either caused or complicated by a bacterial infection, appropriate
antibacterial therapy should be considered in addition to the use of Difflam Forte
Anti-Inflammatory Throat Spray.
Use in Pregnancy
Category B2. Studies in animals are inadequate or may be lacking, but available data
show no evidence of an increased occurrence of foetal damage. The safety of
benzydamine hydrochloride has not been established in pregnant patients. Risk to
benefit ratio should be established if Difflam Forte Anti-Inflammatory Throat Spray is
to be used in these patients.
Drug Interactions
There are no known drug interactions with benzydamine.
Adverse Reactions
Difflam Forte Anti- inflammatory Throat Spray is generally well tolerated and sideeffects are minor. The following adverse reactions have been reported after use of
benzydamine hydrochloride in solution form:
Local Adverse Reactions:
The most commonly reported reaction is oral numbness (2.6% of treated cases).
Occasional burning or stinging sensation may occur (1.4%). Other local adverse
effects were less common and included dryness or thirst (0.2%), tingling (0.2%),
warm feeling in mouth and altered sense of taste (0.1%).
Systemic Adverse Reactions:
These were uncommon and consisted mainly of nausea, vomiting, retching, gastrointestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (0.1%).
Difflam Forte Throat Spray-vs1.doc
Hypersensitivity reactions occur very rarely but may be associated with pruritis, rash,
urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.
Dosage and Administration
Adults and children over 12 years: 2-4 sprays (1-2 mg) directly onto the sore/inflamed
area and swallow gently. Repeat every 1½ to 3 hours as necessary.
Children (6-12 years): 2 sprays (1 mg) directly onto sore/inflamed area and swallow
gently. Repeat every 1½ to 3 hours as necessary.
Children under 6 years: Not recommended.
Uninterrupted treatment should not exceed seven days, unless under medical
supervision.
Cleaning Instructions: After use, wipe the nozzle with a clean tissue to prevent
blockage.
Overdosage
Immediately contact the Poisons Information Centre (telephone 131 126) for advice if
an overdose occurs.
There are no known cases of overdosage with Difflam Forte Anti-Inflammatory
Throat Spray. Adverse CNS effects have been reported following overdosage with
high doses of Difflam Solution. There is no specific antidote for benzydamine. If an
excessive quantity is ingested, the treatment should be symptomatic.
Presentation
White, metered dose, aerosol pump with a green lid containing 15mL of clear
solution.
Storage
Protect from light and store below 25°C.
Poisons schedule
S2
Sponsor
3M Pharmaceuticals Pty Ltd
9-15 Chilvers Road
Thornleigh NSW 2120
AUSTRALIA
ABN 88 000 222 408
Version 1: Prepared: 16 September 2005
Difflam Forte Throat Spray-vs1.doc